BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    MDR report key: 17539755 · Received August 14, 2023

    Report

    Report Number
    0009613350-2023-00456
    Event Type
    Injury
    Date Received
    August 14, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KTT
    PMA / PMN Number
    NOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. THE FOLLOWING SECTIONS WERE CORRECTED: D2, G4. G4: THIS PRODUCT IS NOT CLEARED IN THE US, HOWEVER IS CONSIDERED EQUIVALENT TO 510K K000734. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : ITEM AND LOT NUMBERS ARE UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). G2 ¿ FOREIGN ¿ GERMANY. H3 ¿ OTHER: DEVICE EVALUATION COULD NOT BE PERFORMED AS PART# AND LOT# UNKNOWN. ALSO, DEVICE LOCATION IS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BURSITIS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096836 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE INTERNAL ORTHOPEDIC FIXATION SYSTEM, PLATE/SCREW KTT ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN
    1169986 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE INTERNAL ORTHOPEDIC FIXATION SYSTEM, PLATE/SCREW KTT ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H